Application 020292

Type
NDA
Sponsor
OTSUKA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FERRISELTZFERRIC AMMONIUM CITRATEFOR SOLUTION;ORAL600MG/PACKETNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020292-001FERRISELTZFERRIC AMMONIUM CITRATE600MG/PACKETFOR SOLUTION / ORAL1997-10-14

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N020292-001FERRISELTZ600MG/PACKETFOR SOLUTION / ORAL1997-10-14a50c72e98297…

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
41271ORIG2010-03-03